Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New York, New York 10032


Purpose:

This protocol will assess the cardiovascular risk associated with growth hormone deficiency in adults. We will use multiple modalities to assess risk for heart attacks or strokes including blood work, ultrasound, MRI and endothelial cell biopsies in both patients who are growth hormone deficient and in patients with normal growth hormone secretion. We hypothesize that adults with growth hormone deficiency will have results suggestive of an increased risk for cardiovascular disease.


Study summary:

Subjects will first be tested for possible growth hormone deficiency. This will be done by administering two intravenous medications that should stimulate growth hormone secretion and we will measure growth hormone in the blood every 30 minutes following the administration. Once we have the results on enough subjects we will split the cohort into those subjects who are growth hormone deficient and those who have normal growth hormone. The two groups will each undergo various tests all designed to assess some component of cardiovascular risk. Ultimately we will compare the results of each test to see if those who are growth hormone deficient have an increased risk for cardiovascular disease.


Criteria:

Inclusion Criteria: - Adults 19 years or older who have undergone transsphenoidal surgery for a clinically non-secreting pituitary adenoma Exclusion Criteria: - Currently taking growth hormone, radiation therapy in the past 5 years, changes in dose of other pituitary hormone replacement therapy in past 3 months, taking hydrocortisone (or its equivalent) at a dose of > 30 mg/day, pregnant or nursing women


Study is Available At:


Original ID:

AAAB9681 (Serono-001)


NCT ID:

NCT00720902


Secondary ID:

Serono-001


Study Acronym:


Brief Title:

Adult Growth Hormone Deficiency and Cardiovascular Risk


Official Title:

Assessment of Cardiovascular Risk Markers in GH Deficient Patients With Nonsecreting Pituitary Adenomas


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

19 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Columbia University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

poor enrollment


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Intervention Model:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

8


Enrollment Type:

Actual


Overall Contact Information

Official Name:John C Ausiello, MD
Study Director
Columbia University

Study Dates

Start Date:February 2007
Completion Date:May 2011
Completion Type:Actual
Primary Completion Date:March 2010
Primary Completion Type:Actual
Verification Date:May 2013
Last Changed Date:May 14, 2013
First Received Date:June 16, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Intramyocellular and intrahepatic lipid content using MRI and MR spectroscopy
Time Frame:once
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Carotid intimal-medial thickness studies as assessed by ultrasound
Time Frame:once
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Endothelial function as assessed by flow mediated dilatation and endothelial cell biopsy
Time Frame:once
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Insulin sensitivity as assessed by fasting insulin and glucose levels and by an oral glucose tolerance test
Time Frame:once
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of total body fat, trunk fat and lean body mass by DEXA
Time Frame:once
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Serum cardiovascular risk markers including lipids, CRP, IL-6 and homocysteine
Time Frame:once
Safety Issues:False

Study Interventions

Intervention Type:Procedure
Name:Blood draws
Description:Subjects will have serum cardiovascular markers assessed
Arm Name:A
Intervention Type:Drug
Name:Growth hormone releasing hormone (GHRH) and argini
Description:Subjects will receive GHRH and arginine intravenously and then have blood drawn at frequent intervals over a 90 minutes to assess growth hormone secretion.
Arm Name:A
Intervention Type:Procedure
Name:Carotid ultrasound
Description:Subjects will have an ultrasound of their neck to assess their carotid arteries to look for intima-medial thickness.
Arm Name:A
Intervention Type:Procedure
Name:MRI
Description:Subjects will have MRI and MR spectroscopy of the abdomen and lower extremities to assess for fat in internal organs and muscle.
Arm Name:A
Intervention Type:Procedure
Name:Endothelial cell biopsy
Description:Subjects will undergo endothelial cell biopsies to harvest endothelial cells to study. It will occur once and takes approximately 20 minutes. Patients will have an iv placed and then a sterile wire is passed back and forth in the iv a couple of times. Three wires are passed.
Arm Name:A

Study Arms

Study Arm Type:Active Comparator
Arm Name:B
Description:Patients who have undergone transsphenoidal surgery for pituitary adenoma who are growth hormone deficient.
Study Arm Type:Active Comparator
Arm Name:A
Description:Patients who have undergone transsphenoidal surgery for a pituitary adenoma and have normal growth hormone secretion.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Columbia University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.